Product Liability

Published on: February 19, 2014

In order to allocate more resources to prevent the import of high risk defective drugs the FDA is testing a Secure Supply Chain Pilot Program that allows 13 pharmaceutical companies to have expedited entry for up to 5 drug products

Imported high risk defective drugs are a rising concern for the FDA. The agency wants to spend more resources to fight the “bad guys” and provide incentives to drug manufacturers who are adopting best practices for supply chain integrity by giving them expedited access for the importation of up to five of their drug products. The pilot will last two years and if effective, will be open to additional companies.

Companies that have qualified for the pilot are

• AbbVie Inc.

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Published on: February 18, 2014

Only 10% of defective children’s products that have been subject to a recall are being returned or repaired

By GGCRBHS&M

90% of dangerous and defective children products are not being returned or repaired according to a new report by the Children Safety Advocate Group Kids in Danger. Because it takes an average 14 reports of design complaints and two reports of personal injury related to the product for the manufacturer to initiate a recall, some of the products may have been discarded or may not be used anymore by the parents at the date of the recall. However such a high percentage indicates that many dangerous products that have already injured or killed children are still being used by parents that are unaware of the recall. According to the report, in 2012, 584 incidents and 39 personal injuries were reported after a juvenile product was recalled.

These numbers demonstrate that manufacturers and the Consumer Product Safety Commission have to find a way to better communicate recalls to consumers. The report also shows that social media is a very effective way to communicate recalls but is not used enough by manufacturers.

Parents also have to be responsible and fill out the product registration card for all juveniles products so that the manufacturer can automatically reach out to them in case of a product recall or any other safety issue. Unfortunately only 30% of parents fill out the registration card for juvenile products.

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Published on: February 17, 2014

Graco recalls defective harness buckles used on most toddler convertible car seats and harnessed booster seats manufactured from 2009 to July 2013

By GGCRBHS&M

Two pending product liability lawsuits including one wrongful death lawsuit, 6100 consumer complaints and a recent recall letter from the NHTSA following an Engineering Analysis of the Office of Defects Investigation have convinced Graco Children’s Product to conduct a recall of the seat harness buckles on most of its children car seats models manufactured since 2009. The defective harness buckles are becoming more difficult to open over time or become stuck in the latched position especially if it gets clogged up with food or dirt. Stuck or sticking buckles may prevent or impede the removal of the child from the car seat in a case of an emergency. According to the NHTSA Graco has been named defendant in two product liability lawsuit related to defective harness buckles. The first one is a consumer class action complaint alleging that the buckles is unreasonably difficult to unlatch or simply doesn’t unlatch. The second lawsuit is related to the death of a young child who died in car fire. Plaintiff alleged that parts in Graco car seat design made it extremely difficult to remove a child that was secured in the seat during an emergency. The recalls 3.7 millions units. Parents who own a defective car seat model and have previously registered it with Graco will automatically receive a Consumer Notification Letter with instructions on how to order a buckle repair kit. Parents who didn’t register their products can order the blucke repair kit online.

Click here for complete list of defective models and contact details.

Read the product recall request letter from the NHTSA

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Published on: February 11, 2014

The diabetes drug saxagliptin marketed as Onglyza and Kombiglyze XR) may be a defective drug that increases the risk of hospitalization for heart failure

By GGCRBHS&M

diabetes%20drug.jpg Drug manufacturers are liable for the safety of their products. Mostly for profit reason some trial results may be overlooked and drugs may be launched on the market with dangerous side effects. A recent study published in the New England Journal of Medicine showed that patients with diabetes using the drug saxagliptin had an increased risk to be hospitalized for heart failure.
For this reason The FDA just published a safety announcement that it requested clinical trial data from the manufacturer of saxagliptin to investigate a possible association between use of the type 2 diabetes drug and heart failure.

Read the Safety Announcement from the FDA

Published on: January 22, 2014

Product Liability: Kenmore Oscillating Fan Heaters sold by Kmart and Sears pose a fire and burn hazrad and have been recalled

By GGCRBHS&M

Defective heaters can cause serious personal injury to consumers and should not be used. If you are using a portable heater please make sure that it has been tested under the latest safety standards and that it is not the subject of a recall. Recently Walmart and Sears recalled the the Kenmore Oscillating Fan Heater because it was posing a risk of fire and burns to consumers. A broken motor mount can cause the units to overheat, catch fire and ignite nearby items.

Product Liability: after one child died and another one suffered serious personal injury, Ikea recalls Children’s Wall-Mounted lamp due to strangulation hazard

By GGCRBHS&M

Ikea%20Defective%20Lamp.jpg A 16 month-old child wrongfully died and a 15 month-old child was severely injured after they became entangled in a very popular Ikea’s children’s wall-mounted lamp.

There were 2.9 million lamps sold in the US, 1.1 million in Canada and 23 million worldwide.

Consumers should stop using the defective lamp and contact Ikea at 888 966 4532 for a free repair kit. The repair kit has self-adhesive fasteners for attaching the lamp’s cord to the wall as well as safety instructions.

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Published on: January 14, 2014

Product Liability: New Safety Standard for Infant Bedside Sleepers will prevent Wrongful Death and Personal Injury

By GGCRBHS&M

To prevent wrongful death and personal injury caused by defective or unsafe bedside sleepers a new federal mandatory standard to improve the safety of bedside sleepers was just approved by the Consumer Product Safety Commission (CPSC)

A bedside sleeper is a bassinet that is attached to an adult bed for parents to easily access their infant from their bed. It is intended for babies up to approximately 5 months.

Among the changes, the new standard includes modifications to the existing standard to address fabric-sided enclosed opening entrapment hazards. Between 2007 and 2009, the CPSC received 4 reports of infant wrongful deaths associated with fabric-sided openings on the products.

Published on: January 10, 2014

Product Liability – Defective Medical Device: Class I Recall for Puritan Bennett 840 Series Ventilator by Covidien

By GGCRBHS&M

A class I product recall has been issued by the FDA for the Puritan Bennett 840 Series Ventilator manufactured by Covidien. A software problem may cause the Ventilator to stop functioning, triggering the safety alarm and causing the patient to suddenly be required to breathe on his or her own. This medical device is usually used on critically ill patients who may not be able to breathe without the ventilator. Therefore if the ventilator inadvertently stops the patient may suffer serious personal injury or death.

Read the complete FDA safety Alert

Puritan%20Bennett%20840%20Ventilator%20may%20be%20defectuous.jpg

Published on: December 12, 2013

Product Liability: Don’t be fooled by advertising, the nipple aspirate test doesn’t screen for cancer, the mammogram does!

By GGCRBHS&M

Nipple%20aspirator.png Some companies recently advertised the Nipple Aspirate Test as a method for breast cancer screening. The Nipple AspirateTest consists of using a breast pump to collect fluid from a woman’s nipple to screen for breast cancer. According the the FDA there is absolutely no clinical evidence to support these claims. So far the mammogram, even though it is uncomfortable for women, is the only way to screen for breast cancer.

The company that is promoting this false advertising is Atossa Genetics. Atossa Genetics was issued a warning by the FDA that their test test was misbranded in that its labeling was false or misleading and asking them to address the violation. Atossa Genetics voluntary recalled the ForeCYTE Breast Health Test from the market in October 2013.

In its advertising Atossa Genetics falsely claimed that the test was “literally a Pap smear for breast cancer.”

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Published on: December 11, 2013

Product Liability: The Consumer Product Safety Commission will host a Google + Hangout on Toy Safety on December 17th

By GGCRBHS&M

Toy%20testing.jpg Toy testing, toy recalls, toy related injuries and toy shopping will be the subject of the first Google+ Hangout hosted by the CSPC. John Massale, A CSPC engineer, will describe the toy testing process and spokeswoman Nikki Fleming will there to answer all your questions.

You can post your questions on Twitter using #AskCPSC hashtag or on CPSC’s G+ Hangout event page.